9-ING-41 in Pediatric Patients With Refractory Malignancies.

Neuroblastoma Clinical Trial

Official title: Phase 1 Study of 9-ING-41, a Glycogen Synthase Kinase 3 Beta (GSK 3β) Inhibitor, as a Single Agent or With Irinotecan, Irinotecan Plus Temozolomide, or With Cyclophosphamide Plus Topotecan in Pediatric Patients With Refractory Malignancies.

Status Active, not recruiting

Clinical Trial Summary

9-ING-41 has anti-cancer clinical activity with no significant toxicity in adult patients. This Phase 1 study will study its efficacy in paediatric patients with advanced malignancies.

Clinical Trial Description

9-ING-41 is a first-in-class, intravenously administered, maleimide-based, small molecule, potent selective GSK-3β inhibitor with significant pre-clinical and clinical anticancer activity. In the ongoing Actuate 1801 study in a cohort of over 90 patients with advanced refractory malignancies, 9-ING-41 has exhibited no significant toxicity, including no myelosuppression, and significant anti-tumor activity. 9-ING-41 also has significant pre-clinical ability to reverse pathologic fibrosis in multiple models of pulmonary and pleural fibrosis. 9-ING-41 is very highly active against neuroblastoma in diverse pre-clinical models. This Phase 1 study is designed to evaluate the safety and efficacy of 9-ING-41, as a single agent or in combination with irinitecan, in paediatric patients with advanced malignancies and thus to establish the recommended Phase 2 dose (RP2D) for further paediatric patient studies. ;

Related Conditions & MeSH terms

• Cancer Pediatric
• Diffuse Intrinsic Pontine Glioma
• Meningioma
• Neuroblastoma
• Neuroblastoma Recurrent
• Pediatric Brain Tumor
• Pediatric Cancer
• Pediatric Lymphoma
• Pediatric Meningioma
• Refractory Cancer
• Refractory Neoplasm
• Refractory Tumor

• NCT number: NCT04239092
• Study type: Interventional
• Source: Actuate Therapeutics Inc.
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: June 5, 2020
• Completion date: December 2024